Human immunodeficiency virus (HIV) was first isolated in 1983. The causative agent for AIDS is known to be a virus of the retrovirus family called HIV (human immunodeficiency virus). Infection with HIV does not, however, immediately give rise to overt symptoms of AIDS. Three to six weeks following primary HIV infection more than 50% of individuals develop acute HIV syndrome, which is self limiting. Clinical findings seen during this period include fever, pharyngitis, lymphadenopathy, headache, arthralgia, myalgia, malaise, lethargy, nausea, vomiting, diarrhea, skin rash, mucocutaneous ulceration, meningitis, encephalitis, neuropathy etc. The only indication of exposure to the virus may be the presence of antibodies thereto in the blood of an infected subject who is then described as ‘HIV positive’. The infection may lie dormant; giving rise to no obvious symptoms, and the incubation period prior to development of AIDS may vary from several months to decades. Development of AIDS itself may be preceded by the AIDS-related complex (ARC), which is characterized by unexplained fever, weight loss, chronic cough or diarrhea. The development of AIDS and/or ARC is dependent on breakdown of immune system. The reasons for the variable period between infection with the virus and breakdown of the immune system in an infected individual are poorly understood. Factors at present unknown may trigger proliferation of the virus with consequential disruption of the immune system. The victims of the disease are then subject to various infections and malignancies, which, unchecked by the disabled immune system, lead to death. Thus HIV is characterized by the “acute HIV syndrome” followed by “asymptomatic stage” with clinical latency. Symptomatic stage sets in later with breakdown of immune system, which ultimately leads to the death of the individual infected with HIV.
Though the disease is caused by virus, the morbidity and mortality associated with disease is due to breakdown of immune system. The breakdown of immune system is characterized by decreased CD4+ T lymphocyte count. Because of this reason 1993 revised classification system for HIV infection is based on CD4+ T lymphocyte counts. HIV disease is empirically divided based on CD4+ count which is a measure of immunodeficiency.                a) Early stage CD4+ T cell count more than 500        b) Intermediate stage CD4+ T cell count 200 to 500.        c) Advanced stage CD4+ T cell count less than 200.        
Individuals with nonprogressive HIV disease are found to have steady CD4+ counts. They are also observed to have strong immune response against the virus.
There is evidence that in HIV infection, there is a dramatic loss of CD4+ T-cells, which results in very rapid development of overt symptoms of AIDS. Most AIDs defining opportunistic infections and true malignancies occur in advanced stage of disease where in CD4+ count is less the 200 cells/μL.
CD4+ Count and HIV
Though HIV is a viral infection, viral load can be determined by reasonable accuracy, CD4+ count (a measure of immune status) plays major role in management of HIV due to following reasons.    1. Morbidity and Mortality in HIV infected individuals is due to opportunistic infections. These opportunistic infections define onset of AIDS in HIV +ve individuals. The risk of opportunistic disease increases markedly when CD4+ cell count declines to less than 200 cells/mm3.    2. CD4+ count provides estimate of degree of existing immunodeficiency.            Immune deficiency is responsible for HIV +ve individuals getting converted to AIDS.            3. The initiation of antiretroviral therapy is also dependent on CD4+ count.    4. Outcome of antiretroviral therapy is also dependent on CD4+ count. Higher survival are associated with higher initial CD4+ count.    5. Risk of progression to AIDs defining illness is associated with declining CD4+ count. The risk is lower with higher CD4+ count.    6. Likelyhood of developing AIDs within 3 years is significantly higher when CD4+ count is low (less than 200 CD4+ T cells) compared to high CD4+ T cell count. For viral load of greater than 55 k as per RT-PCR the risk is 32.6% if CD4+ T cell count is more than 500 cells/mm3 compared to 85.5% for individuals with CD4+ count of less than 200 cells/mm3.    7. Similarly for viral load of 20 k-55 k (RT-PCR) the risk of developing AIDs is 9.5% when    CD4+ count is more than 750 cells/mm3 compared to 40.1% when CD4+ count is less than 350 cells/mm3.Goals of Therapy            Maximal and durable suppression of viral load.        Restoration and/or preservation of immunologic function.        Improvement of quality of life.        Reduction in HIV related morbidity and mortality.        
The method to treat HIV includes various therapeutic options. The options include management of symptoms and infections manifesting in HIV infected individuals at various stages of the disease. The antiretroviral drugs are used to keep the HIV infection (viral load) in control. They keep the viral load in control. The early antiretroviral drugs like azothymidine delayed progression of disease and had no significant effect on CD4+ count. Protease inhibitors like indinavir, ritonavir which are introduced recently do improve CD4+ count while reducing viral, load. All the drugs (antiretroviral) have their own side effects. The resistance to drugs is also noted. Thus there is need to provide alternate mechanism of treating HIV.
Since CD4+ count is important in maintaining immunity of individual and decreased CD4+ counts are associated with morbidity and mortality in HIV infection attempts are made to improve immunity for management of HIV. Various efforts have been done towards this end. This has resulted in introduction of immune modifying therapies with or without antiretroviral drugs. They comprise of antigens, cytokines organisms etc.
It has surprisingly been found during the course of research by us that formulations of ‘Mycobacterium w’ (Mw) with or without antigenic and/or immunomodulatory material derived from (Mw) is effective for management of Human Immunodeficiency Virus (HIV) disease/infection.